The Lived Experiences Measured Using Rings Pilot Study (LEMURS-P)
Primary Purpose
Depression, Stress, Sleep
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Moodlifters
Physical Activity
Nature Experiences
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: Current undergraduate student in their first year of school own a mobile device Exclusion Criteria: None
Sites / Locations
- University of Vermont
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
group-based therapy
physical activity
nature experience
self-monitoring
Arm Description
Group therapy delivered via moodlifters
Physical Activity and Exercise
Nature Experiences
Placebo control
Outcomes
Primary Outcome Measures
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
Self Reported Depression
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Self ReportedAnxiety
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
Self Reported Stress
Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale
Self Reported well-being
Stress as measured by the Perceived Stress Scale
Self Reported subclinical stress
Secondary Outcome Measures
Sleep Quality Index
Self Reported Sleep
Oura Ring Sleep Index
Biometric Sleep recorded from an Oura Ring
Medical Outcomes Social Support Survey
Social Support
Full Information
NCT ID
NCT05841979
First Posted
April 6, 2023
Last Updated
July 6, 2023
Sponsor
University of Vermont
Collaborators
MassMutual - Private Industry Funded
1. Study Identification
Unique Protocol Identification Number
NCT05841979
Brief Title
The Lived Experiences Measured Using Rings Pilot Study
Acronym
LEMURS-P
Official Title
The Lived Experiences Measured Using Rings Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 19, 2023 (Anticipated)
Study Completion Date
May 19, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
MassMutual - Private Industry Funded
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The transition to college is a period of elevated risk for a range of mental health conditions. For students with pre-existing mental health diagnoses, the added pressures can exacerbate challenges. Although colleges and universities strive to provide mental health support to their students, the high demand for these services makes it difficult to provide scalable cost-effective solutions. To address these issues, the present study aims to compare the efficacy of three different treatments using a large cohort of 600 students transitioning to college. Interventions were selected based on their potential for generalizability and cost-effectiveness on college campuses. The randomized controlled trial will assign 150 participants to one of four arms: 1) group-based therapy, 2) physical activity program, 3) nature experiences group, or 4) self-monitoring condition as the control group. In addition, biometric data will be collected from all participants using a wearable device to develop algorithmic predictions of mental and physical health functioning. Once recruitment is complete, modeling strategies will be used to evaluate the outcomes and effectiveness of each intervention. The findings of this study will provide evidence as to the benefits of implementing scalable and proactive interventions using technology with the goal of improving well-being and success of new college students.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Stress, Sleep, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group-based therapy
Arm Type
Experimental
Arm Description
Group therapy delivered via moodlifters
Arm Title
physical activity
Arm Type
Experimental
Arm Description
Physical Activity and Exercise
Arm Title
nature experience
Arm Type
Experimental
Arm Description
Nature Experiences
Arm Title
self-monitoring
Arm Type
No Intervention
Arm Description
Placebo control
Intervention Type
Behavioral
Intervention Name(s)
Moodlifters
Intervention Description
Mood Lifters, a novel mental wellness program, was developed as a more accessible means to provide psychotherapy (Votta & Deldin, 2022). Meetings covered biopsychosocial areas and skills that were drawn from multiple therapeutic interventions consistent with a biopsychosocial framework. Areas included physical health, negative thoughts, problem-solving, emotional awareness and regulation, building relationships, behavioral activation, and using a strengths-based approach. ML is delivered by peer leaders who are individuals that have completed the program as well as a training program.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity
Intervention Description
Participants randomized to the exercise arm received 14 weeks of a structured weekly strength and conditioning training program to enhance muscle mass, strength, cardiorespiratory fitness, and overall well-being. The program is based on previous research showing that cardiorespiratory fitness and muscle strength/size can both contribute to decreased mortality/increased longevity and enhanced mental health (Burke et al., 2017; McLeod et al., 2016; Srikanthan & Karlamangla, 2014; Strasser & Burtscher, 2018). The training program consists of three training sessions per week, with one being an in-person group session guided by a certified strength and conditioning specialist. The other two training sessions are self-guided via the mobile app Trainheroic. This weekly training schedule aligns with previous research showing benefits to structuring an exercise program using a variety of social contexts (group setting, own, etc.; Burke et al., 2017).
Intervention Type
Behavioral
Intervention Name(s)
Nature Experiences
Intervention Description
Participants randomized to the Nature Experiences participated in 14 weeks of group and self-directed activities to connect with the natural environment. Weekly group activities will be led by Nature Guides, who are undergraduate and graduate students with extensive outdoor education training. Group activities will last one hour a week and include hiking in forests, walking in parks, bird-watching, mindfulness exercises, and snow activities. Participants will be given a list of self-directed activity suggestions each week. The goal of self-directed activities is to spend an additional two hours in a natural environment each week.
Primary Outcome Measure Information:
Title
Depression as measured by Depression, Anxiety, Stress Survey - 21 (Depression subscale)
Description
Self Reported Depression
Time Frame
Change in depression scores from time of randomization through 5 months
Title
Anxiety as measured by Depression, Anxiety, Stress Survey - 21 (Anxiety subscale)
Description
Self ReportedAnxiety
Time Frame
Change in anxiety scores from time of randomization through 5 months
Title
Stress as measured by Depression, Anxiety, Stress Survey - 21 (Stress subscale)
Description
Self Reported Stress
Time Frame
Change in stress scores from time of randomization through 5 months
Title
Well-Being as measured by Warwick-Edinburgh Mental Well-being Scale
Description
Self Reported well-being
Time Frame
Change in well-being scores from time of randomization through 5 months
Title
Stress as measured by the Perceived Stress Scale
Description
Self Reported subclinical stress
Time Frame
Change in stress scores from time of randomization through 5 months
Secondary Outcome Measure Information:
Title
Sleep Quality Index
Description
Self Reported Sleep
Time Frame
Change in sleep quality scores from time of randomization through 5 months
Title
Oura Ring Sleep Index
Description
Biometric Sleep recorded from an Oura Ring
Time Frame
Change in Oura Sleep measured scores from time of randomization through 5 months
Title
Medical Outcomes Social Support Survey
Description
Social Support
Time Frame
Change in social support scores scores from time of randomization through 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current undergraduate student in their first year of school
own a mobile device
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Bloomfield, MD, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Danforth, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ryan McGinnis, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen McGinnis, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Price, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Lived Experiences Measured Using Rings Pilot Study
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